A mathematical model developed by researchers at Loyola University
in Chicago can predict the length of time patients with hepatitis C
virus (HCV) must remain on direct-acting antiviral (DAA) drugs to
achieve sustained virologic response, according to a new study.
The
investigators used early viral kinetic analysis to test study
participants—58 people with HCV being treated at three medical centers
in France—for blood levels of the virus at the start of the study, on
the second day of treatment, every other week, at the end of the study
and then 12 weeks after the study concluded. The patients were each on
12-week drug regimens: sofosbuvir (Sovaldi, Gilead) and simeprevir
(Olysio, Janssen), sofosbuvir and daclatasvir (Daklinza, Bristol-Myers
Squibb), or ledipasvir-sofosbuvir (Harvoni, Gilead).
They
found that frequent blood testing could predict HCV levels, and
identify which patients would receive cure within six, eight, 10, 12 and
13 weeks of therapy, respectively. For the single patient in the study
who relapsed, the modeling suggested that he would have benefited from
an additional week of ledipasvir-sofosbuvir. Adjusting treatment
according to the model would reduce medication costs by 16% to 20% per
1,000 patients receiving treatment, the study found (J Hepatol 2016 Feb 20. doi: 10.1016/j.jhep.2016.02.022. [Epub ahead of print]).
“This
is the first time this approach has been tested in hepatitis C patients
undergoing DAA treatment,” said co-author Harel Dahari, PhD, an
assistant professor of hepatology at Loyola, in an interview with SPC.
“This initial study is very encouraging. We have found a way to not only
shorten the treatment, but extend it in some patients who may need
that.”
Dr. Dahari explained that, based on the
group’s experience, there are two phases of viral load decline with
current HCV therapies. “After just two days on therapy, there is a very
sharp, rapid decline. Then, there is a longer, slower decline. In order
to predict the point of cure, we need to know where the viral load was
before treatment, then after two days and then a few more time points to
define the second phase. Then we can extrapolate those curves and
individualize the treatment.”
Before this approach
can be adopted broadly, Dr. Dahari said, prospective studies are
needed. But if it proves accurate, it has the potential to offer
significant savings. “In France, based on current prices for the drugs,
we predicted that it would save almost 1 million Euros for every 100
patients treated,” he said.
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